Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV vaccine GSK3003891A · 1 trial · 1 indication
Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CRE\]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.
Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above \[≥\] 37.5 degrees Celsius \[°C\] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| RSV group | EXPERIMENTAL | Subjects in this group will receive a single dose of the RSV vaccine. |
| Boostrix group | ACTIVE_COMPARATOR | Subjects in this group will receive a single dose of Boostrix. |
| Name | Type | Description |
|---|---|---|
| RSV vaccine GSK3003891A | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| Boostrix | BIOLOGICAL | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years of ...
GSK3003891A is an investigational vaccine developed by GSK plc for the prevention of respiratory syncytial virus infections. It is a vaccine modality that has been studied in healthy adult women. It is not an approved product and remains in clinical development.
GSK3003891A is being developed for the prevention of respiratory syncytial virus infections, the condition studied in its clinical program. The completed Phase 2 trial enrolled healthy women aged 18 years and older. No approved indication has been established for this investigational vaccine.
GSK3003891A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this investigational respiratory syncytial virus vaccine.
GSK3003891A is in Phase 2 development. Its single recorded trial, NCT02753413, is a completed Phase 2 study. The vaccine is investigational and has not been approved for any use.
GSK3003891A has been evaluated in one clinical trial, NCT02753413, titled a safety and reactogenicity study of GSK Biologicals' investigational RSV vaccine in healthy women. That Phase 2 trial is completed, was randomized, double blind, and active controlled, and enrolled 102 participants in Belgium.
Yes. The Phase 2 trial NCT02753413 enrolled healthy female volunteers aged 18 years and older. It was conducted in Belgium and assessed safety and reactogenicity of the investigational RSV vaccine GSK3003891A.